FDA Adverse Event
Injury
Summary report: N
PKS OMNI
MDR report key: 2996841
·
Received March 6, 2013
Report
- Report Number
- 2183680-2013-00016
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 4, 2013
- Manufacturer
- GYRUS MEDICAL INC.
- Product Code
- GEI
- PMA / PMN Number
- K081766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN DISCARDED BY THE FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED TO GYRUSACMI THAT MULTIPLE ATTEMPTS TO CUT PEDICLES DURING A LAP HYSTERECTOMY, THE DEVICE WAS NOT ACTUALLY CUTTING BUT WAS CREATING CHAR. THERE WAS NO PATIENT INJURY REPORTED, THE PROCEDURE WAS PROLONGED BY 30 MINUTES, AND CONVERTED USING THE LIGASURE TO COMPLETE. (SEE MFR REPORT # 2183680-2013-00017 FOR SECOND DEVICE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94618 | PKS OMNI | PKS OMNI | GEI | GYRUS MEDICAL INC. | 970010PC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |